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Monday, November 16, 2020 5:07:19 PM
Go Leo & IPIX!
If I were to guess (and I hate guessing about anything related to this stuff), I'd like to think that built into the trial-design, the Bio-Markers likely placed will be fairly close-in, so after a reasonable number of days elapsed from dose administration (let's say 5 days, for example) samples pulled would be subject to viral-titer analysis, whereupon efficacy could be determined to some extent. (B is either reducing the viral load or it isn't, in humans...)
Leo's CRO would likely have a certified lab contracted to do the sample analysis for 3rd party unbiased verification.
I'd think that upon sample-data being compiled and updated for 'interested parties' based on bioMarkers being placed, that some prospective 'partnership' interests might be resolved... (this wouldn't necessarily mean that results would be made immediately public, however.)
FWIW, there was some BP entity that was granted an IND earlier this year, something like 36hrs after package submission (I'm drawing a blank on the company currently). So it CAN go quickly... if the package is super-comprehensive and complete and assuming the pre-IND process was as detailed as possible (is my understanding).
Quote:
If they submit an IND this week, doesn't the FDA have up to four weeks to approve/reject?
Why do you think we'll have interim results in mid December? It seems like we can barely be assured the trial will start by then.
Brilacidin In a human lung cell line infected by SARS-CoV-2, Brilacidin achieved a high Selectivity Index rating of 426.
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